CA2531419C - Procede de stabilisation d'un cryoprecipite de proteines plasmatiques destine a etre soumis a un traitement thermique d'inactivation virale - Google Patents

Procede de stabilisation d'un cryoprecipite de proteines plasmatiques destine a etre soumis a un traitement thermique d'inactivation virale Download PDF

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Publication number
CA2531419C
CA2531419C CA2531419A CA2531419A CA2531419C CA 2531419 C CA2531419 C CA 2531419C CA 2531419 A CA2531419 A CA 2531419A CA 2531419 A CA2531419 A CA 2531419A CA 2531419 C CA2531419 C CA 2531419C
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Canada
Prior art keywords
proteins
stabilizing
viral inactivation
cryoprecipitate
subjected
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Expired - Fee Related
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CA2531419A
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English (en)
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CA2531419A1 (fr
Inventor
Annie Bardat
Edith Begin
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LFB SA
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LFB SA
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Expired - Fee Related legal-status Critical Current
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A61K38/363—Fibrinogen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A61K38/37—Factors VIII
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/39—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Abstract

L'invention concerne un procédé d'obtention de protéines cryoprécipitables, comprenant une étape d'inactivation virale par traitement thermique d'un lyophilisat desdites protéines, comportant, avant la mise des protéines sous la forme de lyophilisat, une étape initiale d'ajout, auxdites protéines, d'une formulation stabilisante et solubilisante comprenant un mélange d'arginine, d'au moins un acide aminé hydrophobe et de citrate trisodique. L'invention concerne également un concentré d~au moins une protéine cryoprécipitable comprenant la formulation stabilisante et solubilisante introduite selon le procédé et susceptible d'être destiné à un usage thérapeutique.
CA2531419A 2003-07-09 2004-07-08 Procede de stabilisation d'un cryoprecipite de proteines plasmatiques destine a etre soumis a un traitement thermique d'inactivation virale Expired - Fee Related CA2531419C (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR03/08403 2003-07-09
FR0308403A FR2857267B1 (fr) 2003-07-09 2003-07-09 Formulation stabilisante et solubilisante pour les proteines cryoprecipitables.
PCT/FR2004/001788 WO2005004901A1 (fr) 2003-07-09 2004-07-08 Procede de stabilisation d’un cryoprecipite de proteines plasmatiques destine a etre soumis a un traitement thermique d’inactivation virale

Publications (2)

Publication Number Publication Date
CA2531419A1 CA2531419A1 (fr) 2005-01-20
CA2531419C true CA2531419C (fr) 2014-12-23

Family

ID=33522899

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2531419A Expired - Fee Related CA2531419C (fr) 2003-07-09 2004-07-08 Procede de stabilisation d'un cryoprecipite de proteines plasmatiques destine a etre soumis a un traitement thermique d'inactivation virale

Country Status (13)

Country Link
US (1) US7727743B2 (fr)
EP (1) EP1648496B1 (fr)
JP (2) JP4925822B2 (fr)
AT (1) ATE546155T1 (fr)
AU (1) AU2004255503B2 (fr)
BR (1) BRPI0412441A (fr)
CA (1) CA2531419C (fr)
DK (1) DK1648496T3 (fr)
ES (1) ES2382934T3 (fr)
FR (1) FR2857267B1 (fr)
IL (1) IL172844A (fr)
PL (1) PL1648496T3 (fr)
WO (1) WO2005004901A1 (fr)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100624013B1 (ko) * 2004-06-25 2006-09-19 주식회사 녹십자홀딩스 동결건조된 알부민 비함유 재조합 사람 혈액응고 제 8인자 제제
US20060019234A1 (en) * 2004-07-22 2006-01-26 Shanbrom Technologies, Llc Modern blood banking employing improved cell preservation composition
FR2874216B1 (fr) 2004-08-16 2006-11-03 Lab Francais Du Fractionnement Procede de preparation d'un concentre de facteur von willebrand (fvw) par voie chromatographique et concentre de fvw susceptible d'etre ainsi obtenu
FR2894831B1 (fr) * 2005-12-16 2008-02-15 Lab Francais Du Fractionnement Colle biologique exempte de thrombine et son utilisation comme medicament.
ES2264403B1 (es) * 2006-06-22 2007-11-01 Grifols S.A. Medio de suspension de hematies.
CA2692165A1 (fr) 2007-06-25 2008-12-31 Amgen Inc. Compositions d'agents de liaison specifiques vis-a-vis du facteur de croissance des hepatocytes
US8349367B2 (en) * 2007-10-12 2013-01-08 Bakaltcheva Irina B Freeze-dried plasma formats for the trauma care field
FR2947181B1 (fr) 2009-06-26 2012-05-04 Lfb Biotechnologies Composition de facteur vii
TW201335181A (zh) * 2012-01-31 2013-09-01 Kieu Hoang ５５種新發現的蛋白質之序列及其應用
WO2018007767A1 (fr) * 2016-07-06 2018-01-11 Laboratoire Francais Du Fractionnement Et Des Biotechnologies Fibrinogène liquide stable
FR3053592B1 (fr) * 2016-07-06 2020-05-29 Laboratoire Francais Du Fractionnement Et Des Biotechnologies Fibrinogene liquide stable
FR3061020B1 (fr) * 2016-12-22 2019-05-17 Laboratoire Francais Du Fractionnement Et Des Biotechnologies Composition de fibrinogene humain
WO2019074886A1 (fr) 2017-10-09 2019-04-18 Terumo Bct Biotechnologies, Llc Récipient de lyophilisation et son procédé d'utilisation
US11609043B2 (en) 2019-03-14 2023-03-21 Terumo Bct Biotechnologies, Llc Lyophilization container fill fixture, system and method of use
WO2023119277A1 (fr) 2021-12-21 2023-06-29 Omrix Biopharmaceuticals Ltd. Compositions de fibrinogène hautement solubles

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4623717A (en) * 1980-03-05 1986-11-18 Miles Laboratories, Inc. Pasteurized therapeutically active protein compositions
US4456590B2 (en) 1981-11-02 1989-05-30 Heat treatment of lyphilized blood clotting factor viii concentrate
DE3203775A1 (de) * 1982-02-04 1983-08-11 Behringwerke Ag, 3550 Marburg Fibrinogenzubereitung, verfahen zu ihrer herstellungund ihre verwendung
US4470968A (en) * 1983-01-13 1984-09-11 Miles Laboratories, Inc. Pasteurized therapeutically active blood coagulation factor concentrates
CA1260389A (fr) 1984-10-10 1989-09-26 Jay A. Levy Plasma humain, fractions de plasma et composes desdites substances exempt de virus, de bacteries et de retrovirus infectieux
JPS6289628A (ja) * 1985-09-11 1987-04-24 Green Cross Corp:The 人フイブリノゲン製剤の加熱処理法
DE3622642A1 (de) * 1986-07-05 1988-01-14 Behringwerke Ag Einkomponenten-gewebekleber sowie verfahren zu seiner herstellung
JPS6419023A (en) * 1987-04-21 1989-01-23 Green Cross Corp Heat treatment of fibrinogen and fibrinogen preparation
DE3729863A1 (de) * 1987-09-05 1989-03-16 Boehringer Mannheim Gmbh Stabilisierte erythropoietin-lyophilisate
FR2632309B1 (fr) 1988-06-07 1990-08-24 Lille Transfusion Sanguine Procede de purification par voie chromatographique de proteines, notamment de facteur viii, et les produits obtenus
AU670793B2 (en) * 1992-04-30 1996-08-01 Alpha Therapeutic Corporation Improved solubilization and stabilization of factor VIII complex
DE4242863A1 (de) * 1992-12-18 1994-06-23 Boehringer Mannheim Gmbh Stabile lyophilisierte pharmazeutische Zubereitungen von G-CSF
GB9424732D0 (en) * 1994-12-08 1995-02-08 Common Services Agency Heat treated blood plasma proteins
AUPO871997A0 (en) * 1997-08-25 1997-09-18 Csl Limited Dried biologically or therapeutically active preparations
DK1018345T3 (da) * 1998-06-26 2009-03-23 Otsuka Pharma Co Ltd Vandoplöselige, törre sammensætninger
JP2000247903A (ja) * 1999-03-01 2000-09-12 Chugai Pharmaceut Co Ltd 長期安定化製剤
JP2001270900A (ja) * 2000-03-23 2001-10-02 Nihon Pharmaceutical Co Ltd フィブリノゲンのウイルス不活化法
US6623717B2 (en) 2001-03-28 2003-09-23 Council Of Scientific And Industrial Research Process for the preparation of LiBF4
JP2003055257A (ja) * 2001-08-10 2003-02-26 Nihon Pharmaceutical Co Ltd 安定な血液凝固第ｘｉｉｉ因子製剤

Also Published As

Publication number Publication date
ATE546155T1 (de) 2012-03-15
US20060247426A1 (en) 2006-11-02
JP2012051895A (ja) 2012-03-15
JP4925822B2 (ja) 2012-05-09
CA2531419A1 (fr) 2005-01-20
FR2857267A1 (fr) 2005-01-14
WO2005004901A1 (fr) 2005-01-20
JP5719266B2 (ja) 2015-05-13
AU2004255503B2 (en) 2010-12-16
ES2382934T3 (es) 2012-06-14
EP1648496B1 (fr) 2012-02-22
EP1648496A1 (fr) 2006-04-26
IL172844A0 (en) 2006-06-11
PL1648496T3 (pl) 2012-07-31
AU2004255503A1 (en) 2005-01-20
FR2857267B1 (fr) 2006-03-10
US7727743B2 (en) 2010-06-01
DK1648496T3 (da) 2012-05-07
IL172844A (en) 2011-11-30
JP2007516187A (ja) 2007-06-21
BRPI0412441A (pt) 2006-09-05

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